Cleared Traditional

VENTLAB PRESSURECHEK DISOSABLE COLUMN MANOMETER (K120118) - FDA 510(k) Clearance

Class II Anesthesiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K120118 · Ventlab Corp. · Anesthesiology device
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May 2012
Decision
128d
Days
Class 2
Risk

K120118 is an FDA 510(k) clearance for the VENTLAB PRESSURECHEK DISOSABLE COLUMN MANOMETER. Classified as Monitor, Airway Pressure (includes Gauge And/or Alarm) (product code CAP), Class II - Special Controls.

Submitted by Ventlab Corp. (Mocksville, US). The FDA issued a Cleared decision on May 24, 2012 after a review of 128 days - within the typical 510(k) review window.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.2600 - the FDA anesthesiology and respiratory device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Ventlab Corp. devices

Submission Details

510(k) Number K120118 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 17, 2012
Decision Date May 24, 2012
Days to Decision 128 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
12d faster than avg
Panel avg: 140d · This submission: 128d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CAP Monitor, Airway Pressure (includes Gauge And/or Alarm)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.2600
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Anesthesiology devices follow this clearance model.

Regulatory Peers - CAP Monitor, Airway Pressure (includes Gauge And/or Alarm)

All 9
Devices cleared under the same product code (CAP) and FDA review panel - the closest regulatory comparables to K120118.
VORTRAN APM-Plus
K182292 · Vortran Medical Technology 1, Inc. · Sep 2019
NS 120P-TRS Airway Pressure Gauge
K180510 · Instrumentation Industries, Inc. · May 2019
NAPA LP-15 Airway Pressure Monitor
K172284 · Drw Medical, LLC · Feb 2018
RESPIRONICS' DIGITAL MANOMETER
K904935 · Respironics, Inc. · Apr 1991
RESPIRONICS BIPAP PRESSURE ALARM (BIPAP P.A.)
K902276 · Respironics, Inc. · Aug 1990
OHMEDA 5500 AIRWAY PRESSURE MONITOR
K864536 · Ohmeda Medical · Jan 1987